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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06707103




Registration number
NCT06707103
Ethics application status
Date submitted
24/11/2024
Date registered
27/11/2024

Titles & IDs
Public title
Tissue Repair Gel in Venous Leg Ulcers in AU/US
Scientific title
A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)
Secondary ID [1] 0 0
BG003
Universal Trial Number (UTN)
Trial acronym
TRIVIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcer 0 0
Venous Ulcer 0 0
Venous Stasis Ulcer 0 0
Venous Stasis 0 0
Wound Heal 0 0
Wound 0 0
Venous Insufficiency of Leg 0 0
Non-healing Wound 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TR987 0.1% gel
Other interventions - Standard of care

Experimental: TR987 0.1% gel + Standard of Care - Participants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.

Other: Standard of Care - Participants will receive Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.


Treatment: Drugs: TR987 0.1% gel
6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)

Other interventions: Standard of care
Standard of Care (wound cleansing/dressings and compression bandaging)
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Change from baseline in participant's perception of pain level at 12 weeks.
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
Timepoint [3] 0 0
12 and 16 weeks
Secondary outcome [4] 0 0
Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Proportion of participants with any significant reduction in pain at or before 12 weeks.
Timepoint [5] 0 0
12 weeks

Eligibility
Key inclusion criteria
* Adults 18 years and older
* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.
* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.
* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.
* Target ulcer age must be = 4 weeks at Screening.
* Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, or TCPo2.
* Body mass index (BMI) = 42 kg/m2.
* HbA1C =12%.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Target ulcer has been treated with prohibited medications or therapies.
* History of radiation at the target ulcer site.
* Target ulcer decreases in area by 30% or more during screening period.
* History of osteomyelitis at the target ulcer within 6 months of screening.
* History of cancer in the preceding 5 years (except as noted in the protocol).
* Participants considered nutritionally deficient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
312
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Clincial Research Site 78 - Orange
Recruitment hospital [2] 0 0
Clincial Research Site 85 - Sydney
Recruitment hospital [3] 0 0
Clincial Research Site 60 - Ivanhoe
Recruitment hospital [4] 0 0
Clincial Research Site 65 - Shepparton
Recruitment hospital [5] 0 0
Clincial Research Site 75 - Nedlands
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [4] 0 0
3630 - Shepparton
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TR Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anhthu Nguyen Vice President, Global Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
(+61) 280 034 554
Fax 0 0
Email 0 0
anhthu.nguyen@trtherapeutics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
If clinical trial data will be published, this relevant information may be available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06707103